ONC’s big deregulatory decision

ONC’S BIG DEREGULATORY DECISION: As the policy world has watched the Trump administration’s deregulatory scythe chop down regulatory outgrowths, one small section of that world has wondered: what about us? Digital health had been relatively untouched, and it was tempting to speculate whether the slash would cut as deeply for health IT as it had elsewhere.

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Speculate no longer! As first reported in POLITICO, ONC is radically rethinking its scheme for EHR certification oversight. (Here’s the blog post announcing the decision.) Of 55 certification procedures, ONC is revising 30 of them to be “self-declaration only” — that is, a vendor can say its products comply without having a testing lab verify that fact.

Additionally, the office announced it would be using enforcement discretion to relieve certification bodies of their randomized surveillance requirements. Instead, ONC will become “complaint-driven.”

— The justification: In a call with reporters, ONC head Don Rucker said the decision was of a piece with the administration’s deregulatory posture. In general, he said, EHRs are “very public products.”

“They have user bases who immediately know something is working or not working,” he said. Rucker specifically cited the eClinicalWorks scandal, given that it was a user, rather than certification testing procedures, that spotted the problem. (Of course it also took years of litigation to solve the problem.)

Rucker also said the requirements are hold-overs from 2014 requirements, and are therefore, well-tested already.

— The reaction? About as you’d expect: Anytime you remove requirements that burdenone segment of the population and benefit another, you can pretty much guess who’s going to be happy (and who’s not going to be happy).

Athenahealth’s director of government and regulatory affairs, Stephanie Zaremba, said the company was “glad to see ONC taking a step to reduce the burden certification places on developers and providers, and look towards a broader reform of the certification program.”

Indeed, Zaremba is hoping for more: “ONC has an opportunity to go further, by supporting and incenting business processes and technology that not only align with government programs, but foster and encourage innovation in service to patient and provider needs.”

Meanwhile, health IT safety advocates were skeptical and concerned. Hardeep Singh, a health IT researcher at the Baylor College of Medicine, raised an eyebrow at the idea. “I am re-certifying for internal medicine boards on an exam this October but would everyone trust me if I just self-declare that I meet certification criteria without an independent exam?” he asked.

Raj Ratwani, a safety expert at MedStar, offered both pros and cons in response to the announcement. While he thought simplification – and focus on vital features of EHRs — could be helpful, he warned it would nevertheless require follow-up. “It will be important to periodically check to ensure that those self-certifications are valid, meaning vendors are actually doing what they are declaring,” he said, noting that the self-attestation process for user-centered design was easily evaded by vendors.

Past administration officials also aren’t necessarily thrilled. Past ONC head Karen DeSalvo acknowledged the certification program could be improved, but cautioned, “our experience and feedback from stakeholders drove us to provide more oversight so we could better protect the safety of care and the financial investments of providers.”

— But what about the customers? Of course, customers’ views also count. Rob Tennant, the director of health IT policy at the Medical Group Management Association, said he read the announcement “with some concern.”

“While we understand the appeal of reducing the administrative burden associated with quality reporting programs, decreasing ONC oversight of EHR software may prove to be counterproductive,” he said, citing the number of products that have been decertified or placed under a corrective action plan under ONC’s standards.

eHealth tweet of the day: Christina Farr @chrissyfarr Now that FDA has provided more clarity around mobile health, is it time for another super-curated "App Store for health"?

FRIDAY! After yet another aggravating airplane-flight-shopping experience — it was so bad the website kept on suggesting a 12:40 a.m. takeoff — your correspondent vowed to actually purchase his flights sooner next time. Then, upon further reflection, he realized he has never felt he purchased his flight at the right time. Is it possible to purchase a flight right on time?Share flight-shopping tips at dtahir@politico.com. Do not discuss valuable private information on social media, but if so must: @David_Pittman, @athurallen202, @DariusTahir, @POLITICOPro, @Morning_eHealth.

PRICE-Y PRIVATE JETS: Our Health Care colleagues, Rachana Pradhan and Dan Diamond, have more investigative reporting to share on Tom Price’s private jet jaunts: according to their reporting, Price has taken at least 24 private jet flights worth at least $300,000 since early May. In at least one of those trips, he spoke about the need to get value for money.

The Doctor-Patient [and Government] Relationship — Join POLITICO for a three-panel event looking at how doctors, patients, caregivers and advocates can navigate complex decision-making — and what policy changes can help make sure that doctors and their patients can decide the best course and get access to innovative and cost-effective therapies. Speakers include Sen. Bill Cassidy (R-La.), Sen. Jeanne Shaheen (D-N.H.), American Medical Association President David Barbe, M.D. and more. Tuesday, Sept. 26 — Doors open at 8:00 a.m. — The Newseum. RSVP: HERE.

CONGRESS STILL SCRAPPING: The whole legislature is still operating under uncertainty with respect to repeal-and-replace. We’ve heard reports that Republican legislators are offering a rich bonus for Alaska under the terms of a deal — presumably to tempt independent-minded Sen. Lisa Murkowski — but the whole thing might be unconstitutional, warns one Georgetown Law professor.

Also, Sens. Lindsey Graham and Bill Cassidy, tired of fighting with a late-night comedian, have decided to debate Sens. Bernie Sanders and Amy Klobuchar on Monday.

SCOREBOARD! SAYS AMA: The American Medical Association is tracking HHS’s moves to deregulate, along with the status of the Association’s top “asks” of the agency — here.

— Interstate Licensure Compact: Illinois is now a “state of principal licensure” under the Interstate Medical Licensure Compact, which allows doctors in the Land of Lincoln to submit their information to the interstate licensure commission. The commission can then determine whether doctors are eligible for the program. If they are, they can receive licenses in other states, the AMA says. The Compact — considered an important infrastructural boost to telehealth, due to its emphasis on physicians practicing across state lines — has hit logistical challenges of late, due to some friction with the FBI about background checks.

— Florida: Prominent telehealth advocate State Sen. Aaron Bean intends to offer a bill boosting telehealth in the state for the 2018 legislative session, local media reports. Among other changes, it would expand Medicaid reimbursement for telehealth.

PDMP AND OPIOID UPDATES: Some developments in the use of IT to combat the opioid crisis:

— National Academy of Medicine report: A report penned by the National Academy of Medicine and commissioned by the National Governors Association, came out today. One recommendation is more notable for what it doesn’t say than what it does: while the report says prescribers should check their PDMPs, it doesn’t mention mandatory requirements at all. (Mandatory check policies are gaining steam; note that prominent Stanford professor Keith Humphreys just tweeted today about the subject. An interesting discussion follows.)

— Lawsuit holds up part of Missouri PDMP: The Missouri county-by-county PDMP experienced a hold-up last week, as one county decided to hit pause on its plans to join the program. Why? The lawsuit from one statewide Tea Party group against the program.

These activist groups are at least the number-two reason why Missouri has had such a long running conflict over a PDMP, so it’s notable that their tactics are obstructing the county-by-county effort, which wereintended to outflank the gridlock in the state legislature.

—An interesting JAMA article about the use of computer-generated “conversational agents” for mental health.

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About The Author

Darius Tahir is an eHealth reporter for POLITICO Pro. Before joining POLITICO, Darius worked for Modern Healthcare (where he covered health care technology) and the Gray Sheet (where he covered medical devices and digital health).

Darius graduated from Stanford in 2009 — meaning he absorbed just enough sunshine and tech optimism to develop a fascination.